Stannous Fluoride

Stannous Fluoride

Stannous Fluoride Recall

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Questions & Answers

Side Effects & Adverse Reactions

Pediatric patients under 12 years of age should be supervised in the use of this product.  Prolonged daily ingestion may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially in areas with high fluoride concentration in drinking water.  Use in pediatric patients under age 6 requires special supervision to prevent repeated swallowing of rinse.  Do not use before mixing with water.  This product may produce temporary surface staining of teeth.  Adequate brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.  Read directions carefully before using.  Keep out of reach of infants and children. 

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

For daily self-applied topical use as a dental caries preventive.  It is well established that a 0.1% stannous fluoride rinse is a convenient way to apply fluoride to the surfaces of teeth to aid in the prevention of decalcification and dental caries.  This is accomplished by increasing the resistance of tooth surfaces to acid dissolution. 

History

There is currently no drug history available for this drug.

Other Information

Stannous Fluoride 0.63% Concentrate Oral Rinse is a stable, water-free concentrate containing 0.63% stannous fluoride for dilution to 0.1% stannous fluoride.  This is a treatment rinse, not a mouthwash.

Active Ingredients:  Stannous Fluoride 0.63% (w/w) (provides 0.1% (w/v) stannous fluoride when mixed).

Stannous Fluoride Manufacturers


  • Cypress Pharmaceutical, Inc.
    Stannous Fluoride (0.63% Stannous Fluoride) Rinse [Cypress Pharmaceutical, Inc.]

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